MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA COCR FEMORAL BALL HEAD; COCR 01.25.015 COCR BALL HEAD 12/14 Ø 28 SIZE XXL +10.5

Model Number	01.25.015
Medical Device Problem Code	Device Appears to Trigger Rejection (1524)
Health Effect - Clinical Code	Unspecified Infection (1930)
Date of Event	01/03/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Batch review performed on 09-jan-2025: lot 2243694: (b)(4) items manufactured and released on 16-12-2022.Expiration date: 2027-12-01.No anomalies found related to the problem.To date, (b)(4) items of the same lot have been sold with no similar reported event during the period of review.Additional devices revised.Batch reviews performed on 09-jan-2025: liner: versafitcup dm 01.26.2852mhc double mobility hc liner 28/dmf (k092265) lot 2417988: 75 items manufactured and released on 03-09-2024.Expiration date: 2029-07-30.No anomalies found related to the problem.To date, (b)(4) items of the same lot have been sold with no similar reported event during the period of review.Liner: mpact dm 01.32.4452cf dm converter g/dmf - tin coated (k211891) lot 2401967: 20 items manufactured and released on 02-09-2024.Expiration date: 2029-07-24.No anomalies found related to the problem.To date, (b)(4) items of the same lot have been sold with no similar reported event during the period of review.Root cause infection is a known possible complication of any surgery.Although no root cause can be established, there is no indication that any issue with the device may have caused or contributed to the event, and the document review does not indicate any potential manufacturing related cause.
Event or Problem Description
The patient had a primary hip surgery on (b)(6) 2024.On (b)(6) 2024, the patient came in reporting pain due to a dislocation of the head from the liner and the cause was unknown.The surgeon revised head, liner and dm converter.The surgery was completed successfully.Mdr 3005180920-2024-01131.On (b)(6) 2025 the patient came in due to signs of an infection and the pathogen is unknown.The surgeon performed a washout and revised the head, liner and dm converter.The surgery was completed successfully.

• Brand Name: COCR FEMORAL BALL HEAD
• Common Device Name: COCR 01.25.015 COCR BALL HEAD 12/14 Ø 28 SIZE XXL +10.5
• Manufacturer (Section D): MEDACTA INTERNATIONAL SA; strada regina; castel san pietro, switzerland 6874 ; SZ 6874
• Manufacturer (Section G): MEDACTA INTERNATIONAL SA; strada regina; castel san pietro, switzerland 6874 ; SZ 6874
• Manufacturer Contact: marco giannessi ; strada regina; castel san pietro, switzerland 6874 ; SZ 6874
• MDR Report Key: 21227335
• Report Number: 3005180920-2025-00008
• Device Sequence Number: 7559738
• Product Code: JDI
• UDI-Device Identifier: 07630030805141
• UDI-Public: 07630030805141
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K072857
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2024
• Device Explanted Year: 2025
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Other
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 01/24/2025

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Model Number: 01.25.015
• Device Lot Number: 2243694
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/03/2025
• Initial Report FDA Received Date: 01/24/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 12/16/2022
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 73 YR
• Patient Sex: Male